Phase 1
Completed N=8
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma
High-risk Neuroblastoma
Source: ClinicalTrials.gov NCT05373901 ↗
Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Oct 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 8; 1 Participants
Summary
This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk neuroblastoma
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
8; 1 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Dinutuximab Beta |
3956.3 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC0-∞) of Dinutuximab Beta |
4228.6 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Dinutuximab Beta |
13.49 | — |
| PRIMARY Time to Maximum Serum Concentration (Tmax) of Dinutuximab Beta |
240.4 | — |
| PRIMARY Half-Life (t1/2) of Dinutuximab Beta |
253.9 | — |
| PRIMARY Clearance (CL) of Dinutuximab Beta |
17.19 | — |
| PRIMARY Volume of Distribution During Terminal Phase (Vz) of Dinutuximab Beta |
6295.9 | — |
| PRIMARY Volume of Distribution at Steady State (Vss) of Dinutuximab Beta |
3594.0 | — |
Eligibility Criteria
- Signed informed consent form (ICF) and ability to comply with study requirements
- Age ≥ 12 months at consent
- Diagnosis of high-risk neuroblastoma according to the International Neuroblastoma Staging System (INSS) criteria.
- Participants who have previously received induction chemotherapy and achieved a partial or complete response followed by myeloablative therapy and stem cell transplantation. Stem cell transplantation should be completed within 120 days of dinutuximab beta first administration
Exclusion Criteria
- Hypersensitivity to ≥ 1 component of dinutuximab beta antibody or against mouse proteins
- Actively progressive disease (not stabilized) or recurrent disease at the time of inclusion into the study
- Previous treatment with anti-GD2 antibody before enrolling in this study
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT05373901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.